FDA Officials Push for Faster Approvals in Cell, Gene, and Rare Disease Therapies
TL;DR Summary
At a June 5 FDA roundtable, officials and experts discussed streamlining regulations to accelerate the development of cell and gene therapies, with suggestions including adopting China's two-tier system and reducing bureaucratic delays, amid concerns over international competition and innovative breakthroughs like CRISPR treatments for rare diseases.
- 'Not a horse and pony show': At FDA cell and gene roundtable, officials look for ways to cut red tape Fierce Biotech
- CBER Roundtable on Cell and Gene Therapy fda.gov
- US Health Secretary Kennedy looks to fast-tracking approvals for rare disease drugs Reuters
- FDA’s Prasad Vows to Make Rare Disease Drugs Available at ‘First Sign of Promise’ BioSpace
- Cell and Gene Therapy Leaders Tell FDA: “Believe in American Solutions” Genetic Engineering and Biotechnology News
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